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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eyelid Thermal Pulsation System
510(k) Number K252409
Device Name TearCare MGX System
Applicant
Sight Sciences, Inc.
4040 Campbell Ave. Suite 100
Menlo Park,  CA  94025
Applicant Contact Rachel Franco
Correspondent
Sight Sciences, Inc.
4040 Campbell Ave. Suite 100
Menlo Park,  CA  94025
Correspondent Contact Rachel Franco
Regulation Number886.5200
Classification Product Code
ORZ  
Date Received08/01/2025
Decision Date 04/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04795752
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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